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Kytril Injection

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Kytril Injection

Kytril Injection Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Kytril (granisetron hydrochloride) Injection is a serotonin-3 (5-HT3) receptor antagonist used alone or with other medications to prevent nausea and vomiting caused by cancer drug treatment (chemotherapy). It is also used to prevent and treat nausea and vomiting after surgery in adults. The brand name of this medication is discontinued, but generic versions may be available. Common side effects include headache, diarrhea, dizziness, fever, or pain/redness/swelling at the injection site.

The recommended adult dosage for Kytril Injection is 10 mcg/kg administered intravenously within 30 minutes before initiation of chemotherapy, and only on the day(s) chemotherapy is given. Kytril may interact with apomorphine, amiodarone, dofetilide, pimozide, procainamide, quinidine, sotalol, and antibiotics. Tell your doctor all medications and supplements you use. During pregnancy, Kytril should be used only if prescribed. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.

Our Kytril (granisetron hydrochloride) Injection Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Kytril Injection Overview - Patient Information: Side Effects

SIDE EFFECTS: Headache, diarrhea, dizziness, fever, or pain/redness/swelling at the injection site may occur. If any of these effects persist or worsen, tell your doctor promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: stomach/abdominal pain.

Get medical help right away if any of these rare but serious side effects occur: chest pain, fast/irregular heartbeat, severe dizziness, fainting.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Kytril Injection (Granisetron Hydrochloride)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Kytril Injection FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

QT prolongation has been reported with KYTRIL [see WARNINGS AND PRECAUTIONS and DRUG INTERATIONS]

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in patients.

Chemotherapy-Induced Nausea and Vomiting

The following have been reported during controlled clinical trials or in the routine management of patients. The percentage figures are based on clinical trial experience only. Table 1 gives the comparative frequencies of the two most commonly reported adverse reactions ( ≥ 3%) in patients receiving KYTRIL Injection, in single-day chemotherapy trials. These patients received chemotherapy, primarily cisplatin, and intravenous fluids during the 24-hour period following KYTRIL Injection administration. Reactions were generally recorded over seven days post-KYTRIL Injection administration.

Table 1: Principal Adverse Reactions in Clinical Trials - Single-Day Chemotherapy

Percent of Patients With Reaction
  KYTRIL Injection
40 mcg/kg
(n=1268)
Comparator1
(n=422)
Headache 14% 6%
Constipation 3% 3%
1 Metoclopramide/dexamethasone and phenothiazines/dexamethasone.

Additional adverse events reported in clinical trials were asthenia, somnolence and diarrhea.

In over 3,000 patients receiving KYTRIL Injection (2 to 160 mcg/kg) in single-day and multiple-day clinical trials with emetogenic cancer therapies, adverse events, other than those adverse reactions listed in Table 1, were observed; attribution of many of these events to KYTRIL is uncertain.

Hepatic: In comparative trials, mainly with cisplatin regimens, elevations of AST and ALT ( > 2 times the upper limit of normal) following administration of KYTRIL Injection occurred in 2.8% and 3.3% of patients, respectively. These frequencies were not significantly different from those seen with comparators (AST: 2.1%; ALT: 2.4%).

Cardiovascular: Hypertension (2%); hypotension, arrhythmias such as sinus bradycardia, atrial fibrillation, varying degrees of A-V block, ventricular ectopy including non-sustained tachycardia, and ECG abnormalities have been observed rarely.

Central Nervous System: Agitation, anxiety, CNS stimulation and insomnia were seen in less than 2% of patients. Extrapyramidal syndrome occurred rarely and only in the presence of other drugs associated with this syndrome.

Hypersensitivity: Rare cases of hypersensitivity reactions, sometimes severe (eg, anaphylaxis, shortness of breath, hypotension, urticaria) have been reported.

Other: Fever (3%), taste disorder (2%), skin rashes (1%). In multiple-day comparative studies, fever occurred more frequently with KYTRIL Injection (8.6%) than with comparative drugs (3.4%, P < 0.014), which usually included dexamethasone.

Postoperative Nausea and Vomiting

The adverse reactions listed in Table 2 were reported in ≥ 2% of adults receiving KYTRIL Injection 1 mg during controlled clinical trials.

Table 2: Adverse Reactions in Controlled Clinical Trials in Postoperative Nausea and Vomiting (Reported in ≥ 2% of Adults Receiving KYTRIL Injection 1 mg)

Percent of Patients With Reaction
  KYTRIL Injection
1 mg
(n=267)
Placebo
(n=266)
Pain 10.1 8.3
Headache 8.6 7.1
Fever 7.9 4.5
Abdominal Pain 6.0 6.0
Hepatic Enzymes Increased 5.6 4.1
Dizziness 4.1 3.4
Diarrhea 3.4 1.1
Flatulence 3.0 3.0
Dyspepsia 3.0 1.9
Oliguria 2.2 1.5
Coughing 2.2 1.1

Additional adverse events reported in clinical trials were constipation, anemia, insomnia, bradycardia, leukocytosis, anxiety, hypotension, infection, hypertension, and urinary tract infection.

In a clinical study conducted in Japan, the types of adverse events differed notably from those reported above in Table 2. The adverse events in the Japanese study that occurred in ≥ 2% of patients and were more frequent with KYTRIL 1 mg than with placebo were: fever (56% to 50%), sputum increased (2.7% to 1.7%), and dermatitis (2.7% to 0%).

Postmarketing Experience

The following adverse reactions have been identified during post approval use of KYTRIL. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to KYTRIL exposure.

QT prolongation has been reported with KYTRIL [see WARNINGS AND PRECAUTIONS and DRUG INTERACTIONS]

Read the entire FDA prescribing information for Kytril Injection (Granisetron Hydrochloride) »

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Kytril Injection - User Reviews

Kytril Injection User Reviews

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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